Cardiovascular Disease, Hypertension, Care Coordination, HIV Treatment Cascade
Conditions
Keywords
HIV, Cardiovascular Disease, Medication Management, Care Coordination
Brief summary
The VA is the largest single provider of HIV care in the US and Veterans with HIV use significantly more healthcare services and have a 1.5-2x higher risk of atherosclerotic cardiovascular disease (ASCVD) compared to uninfected Veterans. The goal is to improve BP treatment for Veterans with HIV to reduce ASCVD risk. Within a randomized controlled trial (RCT), the investigators hypothesize that the VA adapted nurse-led intervention will result in a clinically significant 6 millimeters of mercury (mmHg) reduction in systolic blood pressure (SBP) over 12 months compared to those receiving enhanced education only. The study is innovative because of the use of stakeholder-engaged design process, multi-component nurse-led intervention, and VA Video Connect (VVC) to monitor CVD risk factors. The project meets VA strategic priorities including: 1) greater choice for Veterans; 2) improve timeliness of services; 3) focus more resources more efficiently (strengthen foundational services in VA). If shown to be effective, this intervention will have substantial impact among high-risk Veterans, potentially reducing ASCVD events by more than a quarter.
Detailed description
Background: The VA is the largest provider of HIV care in the United States. The \ 31,000 Veterans with HIV use significantly more healthcare and have up to 2x higher risk of atherosclerotic cardiovascular disease (ASCVD) compared to uninfected Veterans. The HIV treatment cascade model includes care steps; once people obtain remission, providers should focus on preventing ASCVD. The investigators will extend the HIV treatment cascade and focus on reducing ASCVD risk among people with HIV. Veterans with HIV have low perceived risk for ASCVD and uptake of guideline-based treatment for BP is low. Significance/Impact: The proposed intervention has the potential to reduce ASCVD events in this population by more than a quarter and meet VA strategic priorities of: 1) improve timeliness of services; 2) focus resources more efficiently as well as address health systems research (HSR) research priorities: 1) patient centered care, care management, and health promotion; 2) healthcare access; 3) aging; 4) virtual care. Innovation: The study is innovative: Cascade Model. By leveraging the HIV treatment cascade model, the investigators will create a pathway for ASCVD risk reduction to be added into widespread quality improvement initiatives. Stakeholder-engaged design process. The investigators will employ stakeholder-engaged research methods to ensure the intervention meets the needs of patients and healthcare providers. Multi-component nurse-led intervention. While each of the components of the intervention have an evidence base, they have not been tested together in an HIV context. Telehealth. The investigators will use VA Video Connect (VVC) to monitor CVD risk factors. Specific Aims: Aim 1a: Conduct qualitative interviews with Veterans and healthcare providers to ascertain perceptions regarding HIV and CVD risk reductions to inform intervention adaptation. Aim 1b: Adapt the intervention to the VA HIV clinic context with key stakeholder input. Aim 2: Evaluate the 12-month efficacy of a nurse intervention to improve systolic blood pressure in Veterans with HIV. Hypothesis: The investigators hypothesize that the intervention will result in a clinically significant 6mmHg reduction in SBP over 12 months compared to those receiving \[enhanced education + usual care\] only. Aim 3: Conduct an evaluation of the prevention nurse intervention. Exploratory aim: If effective, \[the investigators will conduct a budget impact analysis\] and simulate 10-year cost-effectiveness of the nurse intervention. Methodology: The investigators will conduct qualitative interviews with care team and Veterans to adapt the intervention in an iterative design process. The investigators will then conduct a RCT to evaluate an intervention to reduce ASCVD risk. The study will be conducted in 3 clinics among HIV+ Veterans (n=300) on suppressive antiretroviral therapy (ART) with confirmed SBP \>140 mmHg, stratified by clinic site and randomized 1:1 to intervention vs. education control. The intervention will involve 4 evidence-based components based on the investigators' prior studies and adapted to Veterans with HIV: (1) nurse-led care coordination, (2) nurse-managed medication and adherence support (3) home BP monitoring, and (4) administered VA Video Connect (VVC). The education control will receive enhanced education and usual care. Primary outcome: difference in 12-month systolic BP in the intervention arm vs control. Secondary outcome: 12-month difference in non-HDL cholesterol. The investigators will use a mixed-methods design to evaluate fidelity, dose delivered/received, reach, recruitment, and context of the intervention. Implementation/Next Steps: The investigators designed the intervention with downstream implementation in view. This includes: a fully remote delivery of the intervention to facilitate access and widespread implementation, and guidance for selection of nurses with education / experience levels that match those of health coaches delivering interventions within the VA. The investigators will work with operational partners from the Office of Connected Care and Office of HIV/AIDS care regarding implementation plans. The investigators will disseminate a clinical program, including scripts, and description of all intervention processes, to facilitate implementation within the VA.
Interventions
BEHAVIORALIntervention group
This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist)
BEHAVIORALEducation control group
This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age =\> 18 years 2. Confirmed HIV+ diagnosis 3. Undetectable HIV viral load: defined as the most recent HIV viral load \< 200 copies/mL, checked within the past 18 months (assessed via chart abstraction) 4. Hypertension: defined as the average of 4 most recent outpatient BP measurements in the last 18 months to show systolic BP 130 and/or diastolic 90 mmHg (assessed via chart abstraction) 5. Veteran at one of the sites participating in the study 6. Regular access to a computer, tablet or smart phone device with internet.
Exclusion criteria
1. Severely hearing or speech impaired, or other disability that would limit participation 2. In a nursing home at baseline and/or any long-term care facility. Individuals will be censored at the point of entering nursing home care 3. In-patient psychiatric care 4. Diagnosis of dementia or active psychosis 5. Terminal illness with life expectancy \< 4 months (ex. Metastatic cancer, Hospice care) 6. Recent (\<90day) hospitalization for coronary artery bypass surgery (CABG), myocardial infarction (MI), stroke) 7. Pregnant, breast-feeding, or planning a pregnancy during the study period 8. Planning to move out of the area in the next 12 months. 9. No reliable access to telephone services
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Systolic Blood Pressure | Baseline | Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-HDL Cholesterol | Baseline | Non-HDL Cholesterol will be calculated by Total Cholesterol - HDL Cholesterol and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL) |
Countries
United States
Participant flow
Pre-assignment details
While 305 participants were consented and randomized to an arm, 4 withdrew and did not complete the baseline assessment. 301 is the number that completed baseline assessment and will therefore be used as the baseline analytic population for the study.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Participants randomized to the intervention will have 4 visits over 12 months with study staff. In addition, they will also receive focused communication from the interventionist (nurse or pharmacist), with additional BP monitoring support and medication management for 12 months.
Intervention group: This is a intervention for 12 months which focuses on behavioral and medication management, led by a health coach (nurse or pharmacist) | 152 |
| Education Control Group Participants randomized to the education control group will have 4 visits over 12 months and will receive education materials related to CVD risk reduction.
Education control group: This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months. | 149 |
| Total | 301 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | 12month BP not collected | 4 | 4 |
| Overall Study | Lost to Follow-up | 17 | 18 |
| Overall Study | Withdrawal by Subject | 12 | 4 |
Baseline characteristics
| Characteristic | Total | Education Control Group | Intervention Group |
|---|---|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 9.5 | 61.4 years STANDARD_DEVIATION 9.4 | 62.1 years STANDARD_DEVIATION 9.6 |
| Education College graduate or higher | 90 Participants | 46 Participants | 44 Participants |
| Education High school or less | 80 Participants | 41 Participants | 39 Participants |
| Education Some college or trade school | 131 Participants | 62 Participants | 69 Participants |
| Employment Employed | 119 Participants | 58 Participants | 61 Participants |
| Employment Retired | 109 Participants | 53 Participants | 56 Participants |
| Employment Unemployed | 73 Participants | 38 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 10 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 275 Participants | 136 Participants | 139 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 233 Participants | 115 Participants | 118 Participants |
| Race (NIH/OMB) More than one race | 20 Participants | 11 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 38 Participants | 21 Participants | 17 Participants |
| Region of Enrollment United States | 301 Participants | 149 Participants | 152 Participants |
| Sex: Female, Male Female | 23 Participants | 11 Participants | 12 Participants |
| Sex: Female, Male Male | 278 Participants | 138 Participants | 140 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 152 | 1 / 149 |
| other Total, other adverse events | 0 / 152 | 0 / 149 |
| serious Total, serious adverse events | 18 / 152 | 16 / 149 |
Outcome results
Primary
Mean Systolic Blood Pressure
Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.
Time frame: Baseline
Population: The randomized participants who completed the baseline assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Mean Systolic Blood Pressure | 134.6 mmHg | Standard Deviation 17.3 |
| Education Control Group | Mean Systolic Blood Pressure | 133.3 mmHg | Standard Deviation 15.5 |
Primary
Mean Systolic Blood Pressure
Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.
Time frame: 4 months
Population: Enrolled participants who attended the in-person 4 month outcome assessment visit and had BP taken by study personnel.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Mean Systolic Blood Pressure | 129.7 mmHg | Standard Deviation 14.6 |
| Education Control Group | Mean Systolic Blood Pressure | 129.6 mmHg | Standard Deviation 14.3 |
Primary
Mean Systolic Blood Pressure
Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.
Time frame: 8 months
Population: Enrolled participants who attended the in-person 8 month outcome assessment visit and had BP taken by study personnel.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Mean Systolic Blood Pressure | 130.4 mmHg | Standard Deviation 14.7 |
| Education Control Group | Mean Systolic Blood Pressure | 130.5 mmHg | Standard Deviation 16.6 |
Primary
Mean Systolic Blood Pressure
Mean BP is calculated as the average of 3 BP measurements. Collected during BP outcome assessment conducted at interviews.
Time frame: 12 months
Population: Enrolled participants who attended the in-person 12 month outcome assessment visit and had BP taken by study personnel.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Mean Systolic Blood Pressure | 130.5 mmHg | Standard Deviation 13.4 |
| Education Control Group | Mean Systolic Blood Pressure | 130.6 mmHg | Standard Deviation 17.5 |
Secondary
Non-HDL Cholesterol
Non-HDL Cholesterol will be calculated by Total Cholesterol - HDL Cholesterol and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)
Time frame: Baseline
Population: The number of enrolled participants who visited the lab during their outcome assessment period and had blood lipids measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Non-HDL Cholesterol | 118.0 mg/dL | Standard Deviation 42.6 |
| Education Control Group | Non-HDL Cholesterol | 120.9 mg/dL | Standard Deviation 38.3 |
Secondary
Non-HDL Cholesterol
Non-HDL Cholesterol will be calculated by Total Cholesterol - HDL Cholesterol and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)
Time frame: 4 months
Population: The number of enrolled participants who visited the lab during their 4 month outcome assessment period and had blood lipids drawn.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Non-HDL Cholesterol | 114.1 mg/dL | Standard Deviation 51 |
| Education Control Group | Non-HDL Cholesterol | 115.4 mg/dL | Standard Deviation 34.8 |
Secondary
Non-HDL Cholesterol
Non-HDL Cholesterol will be calculated by Total Cholesterol - HDL Cholesterol and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)
Time frame: 8 months
Population: The number of enrolled participants who visited the lab during their 8 month outcome assessment period and had blood lipids drawn.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Non-HDL Cholesterol | 111.7 mg/dL | Standard Deviation 42.9 |
| Education Control Group | Non-HDL Cholesterol | 116.4 mg/dL | Standard Deviation 37 |
Secondary
Non-HDL Cholesterol
Non-HDL Cholesterol will be calculated by Total Cholesterol - HDL Cholesterol and will be collected by lab personnel during outcome assessments. It is measured in milligrams per deciliter (mg/dL)
Time frame: 12 months
Population: The number of enrolled participants who visited the lab during their 12 month outcome assessment period and had blood lipids drawn.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Non-HDL Cholesterol | 110.8 mg/dL | Standard Deviation 39.7 |
| Education Control Group | Non-HDL Cholesterol | 115.2 mg/dL | Standard Deviation 38.6 |